- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00162747
Topical Therapy for Prevention of Infections in Preterm Infants
September 11, 2005 updated by: Johns Hopkins Bloomberg School of Public Health
Topical Emollient Therapy for Prevention of Infections in Preterm Infants
The purpose of this study is to determine how to best take care of the skin of preterm infants in order to prevent infections through the skin.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The skin of babies who are born too early is not mature, which means they are at risk for infections of the skin or in the body.
Their skin also become very dry, leading to cracking and breakdown, and this may feel painful or uncomfortable for the infant.
Study Type
Interventional
Enrollment
600
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Dhaka, Bangladesh
- Dhaka Shishu Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 months to 8 months (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Preterm infants
Exclusion Criteria:
- Full-term infant
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Three weeks after application of the intervention, blood will be drawn from those enrolled in the control group.
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Secondary Outcome Measures
Outcome Measure |
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Atleast four additional times over the first four weeks of the child's life, the skin will be studied by lightly rubbing the skin with a cotton swab to detect germs on the skin and observing and recording the condition of the baby's skin.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Gary L Darmstadt, MD, Johns Hopkins Bloomberg School of Public Health
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2001
Study Completion
June 1, 2005
Study Registration Dates
First Submitted
September 7, 2005
First Submitted That Met QC Criteria
September 11, 2005
First Posted (Estimate)
September 13, 2005
Study Record Updates
Last Update Posted (Estimate)
September 13, 2005
Last Update Submitted That Met QC Criteria
September 11, 2005
Last Verified
June 1, 2005
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 98-04-21-03-2
- H990772
- 914-2123
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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